Abstract
Background: Fewer than 40% of persons with hypertension in the United States have adequate blood pressure (BP) control. Objective: To compare 2 self-management interventions for improving BP control among hypertensive patients. Design: A 2 × 2 randomized trial, stratified by enrollment site and patient health literacy status, with 2-year follow-up. (ClinicalTrials.gov registration number: NCT00123058) Setting: 2 university-affiliated primary care clinics. Patients: 636 hypertensive patients. Intervention: A centralized, blinded, and stratified randomization algorithm was used to randomly assign eligible patients to receive usual care, a behavioral intervention (bimonthly tailored, nurse-administered telephone intervention targeting hypertension-related behaviors), home BP monitoring 3 times weekly, or the behavioral intervention plus home BP monitoring. Measurements: The primary outcome was BP control at 6-month intervals over 24 months. Results: 475 patients (75%) completed the 24-month BP follow-up. At 24 months, improvements in the proportion of patients with BP control relative to the usual care group were 4.3% (95% CI, −4.5% to 12.9%) in the behavioral intervention group, 7.6% (CI, −1.9% to 17.0%) in the home BP monitoring group, and 11.0% (CI, 1.9%, 19.8%) in the combined intervention group. Relative to usual care, the 24-month difference in systolic BP was 0.6 mm Hg (CI, −2.2 to 3.4 mm Hg) for the behavioral intervention group, −0.6 mm Hg (CI, −3.6 to 2.3 mm Hg) for the BP monitoring group, and −3.9 mm Hg (CI, −6.9 to −0.9 mm Hg) for the combined intervention group; patterns were similar for diastolic BP. Limitation: Changes in medication use and diet were monitored only in intervention participants; 24-month outcome data were missing for 25% of participants, BP control was adequate at baseline in 73% of participants, and the study setting was an academic health center. Conclusion: Combined home BP monitoring and tailored behavioral telephone intervention improved BP control, systolic BP, and diastolic BP at 24 months relative to usual care. Primary Funding Source: National Heart, Lung, and Blood Institute; Pfizer Foundation Health Communication Initiative; and the American Heart Association.
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